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A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma

Phase 1
18 Years
Not Enrolling
Peripheral T-Cell Lymphoma, Diffuse Large B-Cell Lymphoma

Thank you

Trial Information

A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma

The purpose of this study is to find the highest dose of romidepsin that can safely be given
in combination with gemcitabine, dexamethasone, and cisplatin (GDP) without causing very
severe side effects that are not tolerable. This is done by starting at a dose lower than
the one that does not cause side effects in animals. Patients are given romidepsin and GDP
and watched very closely to see what side effects they have and to make sure the side
effects are not severe. If the side effects are not severe, then more patients are asked to
join the study and are given a higher dose of romidepsin (with GDP). Patients joining the
study later on will get higher doses of romidepsin (with GDP) than patients who join
earlier. This will continue until a dose is found that causes severe but temporary side
effects. Doses higher than that will not be given.

Inclusion Criteria:

- Patients with histologically confirmed PTCL. Biopsy proof of disease at initial
diagnosis is mandatory. A biopsy at relapse is preferred but not mandatory.

- Patients must have received one or two previous regimens of therapy for their disease
(salvage chemotherapy plus autologous stem cell transplantation is considered to be
one regimen).

- Clinically and / or radiologically measurable disease (1 site bidimensionally
measurable). Measurements / evaluations must be done within 28 days prior to

- Age 18 to 75 years.

- ECOG performance status 0, 1 or 2.

- Life expectancy of ≥ 90 days (3 months).

- Laboratory Requirements: (must be done within 7 days of registration)


- Granulocytes (AGC) ≥ 1.0 x 10^9/L

- Platelets ≥ 75 x 10^9/L (≥ 50 if bone marrow involvement by lymphoma)


- AST and ALT ≤ 2.5x ULN (≤ 5x ULN if hepatic involvement of disease)

- Serum total bilirubin ≤ 1.5x ULN (≤ 3x ULN if hepatic involvement of disease, or ≤5x
ULN if Gilberts Disease)

- Serum Potassium ≥ 3.8 mmol/L*

- Serum Magnesium ≥ 0.85 mmol/L* * NB: Patients with potassium and magnesium levels
below these values are eligible if supplementation has corrected these deficits. This
supplementation should continue throughout the course of the study.

- Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 50 mL /min.

- Women must be post-menopausal, surgically sterile or use reliable forms of
contraception while on study and for 90 days after discontinuing therapy. Women
of childbearing potential must have a pregnancy test taken and proven negative
within 7 days prior to registration and must not be lactating.

- Patient consent must be obtained according to local Institutional and/or
University Human Experimentation Committee requirements.

- Patients must be accessible for treatment and follow-up. Patients registered on
this trial must be treated and followed at the participating centre. This
implies there must be reasonable geographical limits (for example: 1 ½ hour's
driving distance) placed on patients being considered for this trial.

- In accordance with NCIC CTG policy, protocol treatment is to begin within 2
working days of patient registration.

Exclusion Criteria:

- Patients with a history of other malignancies, except: adequately treated
non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ
cancer of the cervix or breast, or other solid tumours curatively treated with no
evidence of disease for ≥ 5 years.

- Central nervous system involvement, meningeal or parenchymal. Patients with CNS
disease at initial presentation and who are in a CNS CR at the time of relapse are
eligible. MRI scanning and / or lumbar puncture should be performed if there is
clinical suspicion of active CNS disease.

- HIV, active hepatitis B or current hepatitis C infection. (Hepatitis B core antibody
positive, surface antigen negative patients allowed if concurrent anti-viral
prophylaxis is administered. Patients with a past history of hepatitis C who have
eradicated the virus are eligible.)

- Any serious active disease or co-morbid medical condition, laboratory abnormality, or
psychiatric illness that would prevent the patient from participating (according to
investigator's decision).

- Patients with serious cardiac illness or condition including, but not limited to:

- history of documented congestive heart failure (CHF)

- systolic dysfunction (LVEF < 45% by MUGA or ECHO)

- high risk uncontrolled arrhythmias (ventricular tachycardia, high-grade
AV-block, supraventricular arrhythmias which are not adequately rate-controlled)

- unstable angina pectoris requiring anti-anginal medication

- clinically significant valvular heart disease

- evidence of transmural infarction on ECG

- New York Heart Association (NYHA) Class III or IV functional status

- patients with congenital long QT syndrome, history of significant cardiovascular
disease and/or taking drugs leading to significant QT prolongation

- patients with QTc > 480 msec are not eligible

- Pregnant or lactating females or women of childbearing potential not willing to use
an adequate method of birth control for the duration of the study.

- Patients with active or uncontrolled infections, or with serious illnesses or medical
conditions which would not permit the patient to be managed according to the protocol
are not eligible.

- Patients are not eligible if they have a known hypersensitivity to the study drugs or
their components.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of combined romidepsin, gemcitabine, dexamethasone and cisplatin.

Outcome Description:

Combination of GDP with romidepsin at the maximum tolerated doses of these agents will identify the combination regimen for comparison in the subsequent randomized phase II trial; if romidepsin appears to improve the activity of GDP, then this will move forward to a formal phase III comparison to CHOP. Primary end points are toxicity, the maximum administered dose and the recommended phase II dose.

Outcome Time Frame:

48 months

Safety Issue:


Principal Investigator

Anthony J Reiman

Investigator Role:

Study Chair

Investigator Affiliation:

Atlantic Health Sciences Corp - Saint John Regional Hospital, Saint John NB Canada


Canada: Health Canada

Study ID:




Start Date:

May 2013

Completion Date:

May 2017

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral